Retinoblastoma Clinical Trial
Official title:
A TRIAL OF ADJUVANT CHEMOTHERAPY IN PATIENTS WITH INTRAOCULAR RETINOBLASTOMA
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating
patients with retinoblastoma.
OBJECTIVES: I. Estimate the response rate to adjuvant carboplatin (CBDCA) alone in children
with intraocular retinoblastoma. II. Assess the overall survival, disease-free survival, and
time to treatment failure in these patients. III. Attempt to maintain a 90% disease-free
survival rate with this treatment. IV. Estimate the percentage of disease-free survivors who
do not require the use of radiotherapy after adjuvant CBDCA. V. Assess the toxicity of this
treatment. VI. Estimate the percentage of functional eyes salvaged using this
radiation-sparing protocol and compare these results, in a nonrandomized manner, with
historical treatment results in this population.
OUTLINE: Patients are stratified according to vitreous disease (yes vs no). Patients receive
carboplatin IV over 1 hour on day 0. Treatment repeats every 2-3 weeks for 2 courses.
Patients achieving complete response (CR) proceed to local control measures consisting of
cryotherapy, laser photocoagulation, etc. (except brachytherapy). Patients not achieving CR
continue with carboplatin until local control measures feasible. Patients with vitreous
disease achieving CR receive 2 additional courses and then receive local control measures.
Patients with vitreous disease not achieving CR receive intensive chemotherapy. Patients
receive intensive chemotherapy consisting of vincristine IV on days 0, 7, and 14, cisplatin
IV over 6 hours on day 0, etoposide IV on days 1 and 2, followed by cyclophosphamide IV over
60 minutes on days 1 and 2. Patients receive filgrastim (G-CSF) subcutaneously beginning on
day 3 and until blood counts recover. Treatment repeats every 2-4 weeks for 2 courses beyond
CR. Patients are followed for 3 years.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study over 5-6 years.
;
Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04564521 -
Nitroglycerin for Intra-arterial Chemotherapy in Pediatric Retinoblastoma.
|
N/A | |
Recruiting |
NCT02933333 -
G-CSF Alone or Combination With GM-CSF on Prevention and Treatment of Infection in Children With Malignant Tumor
|
Phase 4 | |
Withdrawn |
NCT01151748 -
Intra-arterial Chemotherapy for Advanced Intraocular Retinoblastoma
|
Phase 2 | |
Completed |
NCT01048892 -
Seneca Valley Virus-001 and Cyclophosphamide in Treating Young Patients With Relapsed or Refractory Neuroblastoma, Rhabdomyosarcoma, or Rare Tumors With Neuroendocrine Features
|
Phase 1 | |
Active, not recruiting |
NCT00360750 -
Chemotherapy With or Without Radiation Therapy or Observation in Treating Young Patients With Advanced Retinoblastoma Who Have Undergone Surgery to Remove the Eye
|
N/A | |
Completed |
NCT00003173 -
High-Dose Thiotepa Plus Peripheral Stem Cell Transplantation in Treating Patients With Refractory Solid Tumors
|
Phase 2 | |
Enrolling by invitation |
NCT06227962 -
Cognitive Functioning and Health Related Quality of Life in Retinoblastoma Survivors
|
||
Completed |
NCT01661400 -
Anti-Angiogenic Therapy Post Transplant (ASCR) for Pediatric Solid Tumors
|
Phase 1 | |
Terminated |
NCT02617862 -
PCI Imaging System in Pediatric Ophthalmology
|
N/A | |
Recruiting |
NCT02329002 -
SPT Screening in Irradiated Hereditary Retinoblastoma Survivors
|
N/A | |
Terminated |
NCT01466855 -
A Study of Intra-Ophthalmic Artery Topotecan Infusion for the Treatment of Retinoblastoma
|
Early Phase 1 | |
Completed |
NCT01505569 -
Auto Transplant for High Risk or Relapsed Solid or CNS Tumors
|
N/A | |
Completed |
NCT00002515 -
Combination Chemotherapy Followed by Bone Marrow Transplantation in Treating Patients With Rare Cancer
|
Phase 2 | |
Enrolling by invitation |
NCT03655223 -
Early Check: Expanded Screening in Newborns
|
||
Completed |
NCT06367569 -
Evaluation of MRI of the Pineal Gland in Retinoblastoma
|
||
Completed |
NCT02193724 -
Feasibility of Generating Pluripotent Stem Cells From Patients With Familial Retinoblastoma
|
||
Completed |
NCT01884194 -
Morphological Analysis of the Pineal Gland in Pediatric Retinoblastoma Patients Using Magnetic Resonance Imaging
|
N/A | |
Terminated |
NCT01393769 -
Intra-arterial Chemotherapy With Melphalan for the Treatment of Retinoblastoma (RTB) in Advanced Intraocular Stage
|
Phase 2 | |
Completed |
NCT00006246 -
Busulfan in Treating Children and Adolescents With Refractory CNS Cancer
|
Phase 1 | |
Terminated |
NCT00003926 -
Amifostine to Protect From Side Effects of PSCT in Treating Patients With Solid Tumors
|
Phase 1 |